CPHS Meetings
CPHS meetings are held on the first Friday of even-numbered months (February, April, June, August, October, and December) from 8:30 AM to 5:00 PM. Meetings are held in Sacramento at 400 R Street, Room 300, Sacramento, CA. The schedule and location of upcoming meetings are available on the Public Meetings page of the OSHPD Website. Directions to meeting locations are provided on this page. Researchers are encouraged to appear in person, but can attend by telephone if arrangements are made in advance with the CPHS Administrator. All meetings are open to the public and conducted in compliance with the Bagley-Keene Act.

Notification of Researchers
Researchers will be notified in writing of CPHS decisions within 3 weeks of each meeting. Written responses to expedited review applications will be received within 4 weeks of receipt by the CPHS. Researchers are encouraged to contact CPHS staff with questions or comments.

CPHS Members
The 13 CPHS members are appointed by the Secretary of the California Health and Human Services Agency (CHHS). Members are chosen for their expertise in differing fields of research and abilities to represent and understand the needs of diverse research subjects, particularly those who may be vulnerable due to factors such as age, socio-economic status, ethnicity, or medical conditions. CPHS is in compliance with federal regulations stipulating that: at least one member has primary concerns in scientific areas; at least one member has primary concerns in nonscientific areas; and at least one member not be affiliated with CHHS directly or through an immediate family member. All CPHS members are required to avoid influencing or voting on committee motions regarding research proposals with which they may have conflicts of interest. Detailed information about current CPHS members is available on the Committee Members page.

Mission and Purpose

The CPHS serves as the institutional review board (IRB) for the CHHS. Established in 1976 in the wake of revelations about improprieties in research studies, such as the Tuskegee Syphilis Study, the role of the CPHS and other IRBs is to assure that research involving human subjects is conducted ethically. In this task the CPHS is guided by principles delineated in the Belmont Report, which was issued by the U.S. Department of Health, Education, and Welfare in April 1979. These principles include:

Respect for Persons
"Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy."

Beneficence
"Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being….Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harm."

Justice
"…the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research."

Scope of AuthorityUnder the Federalwide Assurance, the CPHS is obligated to review all research involving human subjects for compliance with the Common Rule meeting any of the following criteria:

Research funded by CHHS or any of its departments.

Research conducted by or under the direction of any employee or agent of the Agency or any of its departments.

Research using personally identifiable data held by CHHS or any of its departments.

Research involving subjects for whom CHHS or any of its departments have direct responsibility, such as patients in State hospitals.

CPHS may also review a limited number of research projects for public entities that do not meet the criteria listed above. Contact the CPHS Administrator to inquire about whether a project that does not meet these criteria may be considered for CPHS review.

In compliance with the California Information Practices Act, as amended in 2005, CPHS approval is required for the release for research purposes of any identifiable personal information held by any state agency. This review may employ a more limited set of procedures and criteria (described below in the California Information Practices Act section) if the personal information is held by a department outside of the CHHS.

Reciprocity with Other Institutional Review Boards
The CPHS currently serves as the IRB for selected research involving other institutions with current Federalwide Assurances (FWA) in place. Investigators may apply for an FWA from the Department of Health and Human Services, Office of Human Research Protections. CPHS has begun entering into agreements with a limited number of IRBs to rely on those IRBs to review projects for the CPHS. If a researcher or an IRB is interested in entering into an agreement with CPHS to rely on CPHS or for CPHS to rely on another IRB a request may be submitted in writing to the CPHS Administrator through the CPHS web-based project system, e-Protocol. It is advised that the investigator contact the CPHS Administrator prior to submitting a request for CPHS to rely on another IRB.

There are three Authorization Agreements that may be submitted:

If another IRB is requesting reliance on CPHS to review a project or a class of projects.

If another IRB wants to request that CPHS rely on that IRB to review projects or class of projects. If an institution does not have an IRB, that organization may request that CPHS provide an IRB review. The IRB must also submit proof of having a current FWA.
This request should be made through a submission to the CPHS web-based project submission system, e-Protocol.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

CPHS will review requests on a case-by-case basis. The CPHS does not rely upon other IRBs for reviews for compliance with the California Information Practices Act.

Categories of Research

What is Research?
The Common Rule (§46.102d) defines research as: “...a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities, which meet this definition, constitute research for purposes of this policy, whether or not they are conducted or supported under a program, which is considered research for other purposes. For example, some demonstrations and service programs may include research activities."

The key concept in this definition is that the primary intent of the activity is to create generalizable knowledge. The administrator of the organization undertaking a project may decide whether a project constitutes research according to the Common Rule. OHRP, the federal entity in the Department of Health and Human Services that oversees IRBs, has a series of decision charts that may be very helpful in the process of deciding on whether a project is research. Data collection or inquiries, which are carried out for program evaluation purposes only and will not be used to create generalizable knowledge, are not research. The publication of an article about an evaluation does not, in itself, define the activity as research.

There may be instances when it is not clear as to whether a project constitutes research. In these cases, a request can be made for the CPHS to determine whether a project constitutes research by following instructions in Section V below.

Distinguishing Public Health Practice from Research
CPHS recognizes that public health authorities must be free to conduct routine disease surveillance and perform interventions to protect the health of the public without prior institutional review board approval. The CPHS considers the following factors to be important in determining that an activity qualifies as public health practice instead of research:

The activity is carried out under the direct supervision of a governmental public health agency.

The activity addresses an important health issue for the population under the authority of the public health agency and is carried out for the benefit of that population.

The activity constitutes accepted public health or medical practice and is not designed to test an experimental hypothesis, drug, or device.

The public health authority has pre-existing legal authority to receive any confidential, identifiable information to be used in the activity.

Additional Considerations:

Surveillance or study of highly personal behaviors, particularly with vulnerable populations, in general, should be considered research, and thus requires institutional review board approval.

Publication of information obtained from public health practice or surveillance does not, in itself, indicate that the activity is research.

Identifiable data obtained from public health surveillance activities may not be shared or used for research purposes without institutional review board approval.

Exempt Research
The Common Rule (CFR, §46.101) exempts certain types of research from IRB review. These include:

Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under the second bullet above if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Research involving the collection or study of existing data, documents, records, pathological specimen, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (Please note: Though exempt from review under the Common Rule, CPHS is required to review projects where the investigator records information from personally identified data per the California Information Practices Act).

Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Researchers are not permitted to independently determine that their activities satisfy these criteria for exemption. OHRP has a useful set of decision charts to assist researchers and staff from entities sponsoring the research or providing the data to evaluate whether a research project may be exempt from IRB review. Researchers must apply to the CPHS for exemption following instructions in Section V below.

Research projects that are determined by CPHS to be exempt from review under the federal Common Rule must still be reviewed by CPHS for compliance with the California Information Practices Act if they involve the release of confidential data held by any state agency.

Research under Health Insurance Portability and Accountability Act (HIPAA)
Under the Privacy Rule of the Health Insurance Portability and Accountability Act, as of April 1, 2003, “covered entities” (health plans, health care providers, and health care information clearinghouses) cannot release protected health information for research unless the patients have signed an authorization for release or a waiver of authorization has been approved by an IRB or a Privacy Board. Some CHHS programs are considered covered entities for HIPAA purposes and some CHHS-funded projects use protected health information from HIPAA-covered entities. The CPHS reviews applications for waivers of authorization or alterations of authorizations under HIPAA as part of its normal review of such research projects under the Common Rule.

HIPAA waivers and alterations of authorization are only required when protected health information is first being requested and when there are any changes to the study that affect the HIPAA waiver or authorization. Only one IRB approval of waiver or alteration of patient authorization is required. If another IRB has approved the waiver or alteration, that documentation should be submitted to CPHS with the protocol.

The CPHS will not review research proposals solely for the purpose of granting waivers or alterations of authorization for HIPAA. HIPAA covered entities within CHHS are responsible for compliance with all administrative requirements under HIPAA, including providing, upon request, accountings to individuals of disclosures of protected health information for research purposes.

Submission of Projects

General Guidelines

All materials must be transmitted to the CPHS Administrator through the CPHS web-based project submission system, e-Protocol.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Materials must be submitted no less than 4 weeks before the next meeting in order to be reviewed by CPHS at the meeting.

Determination of Whether Project Requires CPHS Approval

To apply for CPHS to make a determination of whether a project is research a submission must be made through the CPHS web-based project submission system, e-Protocol.

To apply for exemption of a research study from CPHS review, researchers are required to submit a request through e-Protocol. If CPHS decides that a study is exempt, it will not require CPHS review unless revisions are made to the study that do involve non-exempt research. For guidance on whether a research project may be exempt, see Section IV above and OHRP decision charts.

Please note that the Principal Investigator (PI) must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

New Projects

Types of Reviews
There are two types of CPHS review, Common Rule review and California Information Practices Act review. The type of CPHS review required is based on three factors:

Whether the proposed project will involve CHHS staff, CHHS funding, or subjects under custodial care of a CHHS department (e.g., State hospital patients)

Whether the proposed project will involve using protected data held by a CHHS department

Whether the proposed research project will involve contact with human subjects (not just use of data).

New Project Review under the Common Rule
All new research projects submitted to CPHS must be done so through the CPHS web-based project submission system, e-Protocol. New research projects that involve contact with human subjects, such as conducting a survey or collecting specimens require review and approval through a Full Committee Review. For projects, such as data-only studies, eligible for expedited review an e-Protocol submission will be reviewed through Expedited Review. For information on expedited review see section VI. CPHS Processes of Review, Expedited Review.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Please Note: If a project will utilize Office of Statewide Health Planning and Development (OSHPD) data, submit the CPHS protocol through the web-based project submission system, e-Protocol. You must additionally submit OSHPD-required paperwork to OSHPD at this time. Please contact OSHPD Health Information Resource Center staff at 916-326-3802 or hircweb@oshpd.ca.gov to arrange this review.

New Project Review under the California Information Practices Act (IPA)
All research projects that are only submitted to CPHS because of a request for protected information from a state department, including departments within CHHS, require only an IPA review. CPHS defines protected information for health data to be any of the 18 HIPAA identifiers or any data that may allow the identification of participants. See the list of HIPAA Identifiers.

For research projects involving the release of identifiable personal information held by a state department, and for which submission of a full research protocol for review under the federal Common Rule is not necessary, researchers are required to submit a protocol through the CPHS web-based project submission system, e-Protocol. For a complete list of instructions regarding e-Protocol, please refer to the CPHS e-Protocol User Manual here.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Information Practices Act studies will be approved on an expedited basis by the CPHS Chair, Vice Chair and/or a member designee. If the reviewers do not approve the project, it will be referred to the full committee for consideration at a convened meeting.

Continuing Projects
Previously approved projects may be reviewed for three reasons:

Routine periodic review (approval is for a period specified by the Committee, usually annually for low risk projects, but never for more than 364 days). Please note that projects exclusively using death data files are not subject to periodic review.

Review for changes to a continuing project. Please note that if a project is being submitted for changes, it may also be submitted for periodic review if it is submitted within 5 months of the expiration date of the project.

Compliance with the Information Practices Act. Continuing Projects will be reviewed for compliance with the California Information Practices Act when state agencies are releasing personally identified information for purposes of the project.

Periodic Review for Common RuleAll projects must submit a periodic review for research projects continuing beyond one year. Projects should be submitted to CPHS through the CPHS web-based project submission system, e-Protocol. The project may be reviewed through an Expedited Review (see Expedited Review in VI. CPHS Processes of Review for clarifications of which projects are eligible).

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Please Note: If OSHPD data has not been requested in previous protocols but is now being requested, submit the CPHS protocol through the web-based project submission system, e-Protocol. You must additionally submit OSHPD-required paperwork to OSHPD at this time. Please contact OSHPD Health Information Resource Center staff at 916-326-3802 or hircweb@oshpd.ca.gov, to arrange this review.

If changes to the project design or materials are proposed as part of the periodic project review, these must be described and justified in an e-Protocol submission. Proposed project changes must be reviewed and approved by the CPHS before being implemented. In the rare event, if the project changes must be made without prior CPHS approval in order to protect subject safety and welfare, the CPHS must be immediately notified.

Annual Review for Information Practices Act
All projects that are continuing beyond the first year must be approved annually. All continuing review research projects should be submitted to CPHS through the CPHS web-based project submission system, e-Protocol.

Review for Changes under the Common Rule
Proposed project changes must be reviewed and approved by the CPHS before being implemented. In the rare event, if the project changes must be made without prior CPHS approval in order to protect subject safety and welfare, the CPHS must be immediately notified.

Please Note: If OSHPD data has not been requested in previous protocols but is now being requested, submit the CPHS protocol through the web-based project submission system, e-Protocol. You must additionally submit OSHPD-required paperwork to OSHPD at this time. Please contact OSHPD Health Information Resource Center staff at 916-326-3802 or hircweb@oshpd.ca.gov, to arrange this review.

Researchers may request expedited review of minor changes by the project's primary reviewer and the CPHS Chair or Vice-Chair. Expedited review of minor changes requires a submission to the CPHS through the CPHS web-based project submission system, e-Protocol.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Examples of minor changes include:

Wording changes that do not substantially alter the meaning of project protocols, informed consent documents, or project materials.

Changes in the research period.

Changes in database years or variables if the changes do not present additional risks of loss of confidentiality.

Changes in subject number or subject selection procedures.

Researchers are advised to consult with the CPHS Administrator regarding whether proposed changes qualify as minor. Project changes that are not minor must be reviewed and approved by the full CPHS in a convened session and require the submission through the CPHS web-based project submission system, e-Protocol. If the project protocol is revised, the principal investigator and the responsible institutional official must approve the revisions in the e-Protocol system.

If a project with proposed changes is subject to periodic review within 5 months of the request to the CPHS for changes, the principal investigator may request that the periodic review be performed at the same time as the review of changes. This will require that the principal investigator additionally submit a request for early periodic review, which can be done by submitting a periodic review through e-Protocol. If the CPHS approves the periodic review, the timing for the subsequent periodic review will be based upon the new approval date.

Review for Changes under the Information Practices Act
If there are proposed revisions at any time other than the annual review, a request for a revision must be submitted to CPHS for review and CPHS must approved those changes before any project changes are implemented. Requests for revisions must be completed online and need to be submitted to CPHS through the CPHS web-based project submission system, e Protocol.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

The CPHS may revoke its approval under the California Information Practices Act if it determines that changes in the project protocol or procedures or principal investigator have been carried out without prior CPHS approval.

Completed Projects under the Common Rule

Projects that have been successfully completed require a submission to CPHS through the CPHS web-based project submission system, e-Protocol. For a complete list of instructions regarding e-Protocol, please refer to the CPHS e-Protocol User Manual here.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

PLEASE NOTE: Projects in the data analysis phase should not be considered completed. These projects should be considered continuing and subject to periodic review requirements. Projects may be considered completed if they are in the publication stage, as long as there will be no further data analysis. In addition, personally identified data must be destroyed or returned as required in the original protocol.

Completed Projects under the Information Practices Act

Projects that have been successfully completed require a submission to CPHS through the CPHS web-based project submission system, e-Protocol. For a complete list of instructions regarding e-Protocol, please refer to the CPHS e-Protocol User Manual here.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Withdrawn Projects under the Common Rule

Projects that have been withdrawn require a submission to CPHS through the CPHS web-based project submission system, e-Protocol. For a complete list of instructions regarding e-Protocol, please refer to the CPHS e-Protocol User Manual here.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

In addition, personally identified data must be destroyed or returned as required in the original protocol.

Withdrawn Projects under the Information Practices Act

Projects that have been withdrawn require the submission to CPHS through the CPHS web-based project submission system, e-Protocol. For a complete list of instructions regarding e-Protocol, please refer to the CPHS e-Protocol User Manual here.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

In addition, personally identified data must be destroyed or returned as required in the original protocol.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Once the project has been submitted, you must contact the VSAC Administrator at:

After these documents are reviewed by the Vital Statistics Advisory Committee, VSAC staff will forward the review to CPHS.

NOTE: For projects using other databases in addition to death data files and/or with human subjects contact submit a complete research application through the CPHS web-based project submission system, e-Protocol.

Please note that each Principal Investigator(PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Once CPHS approval is granted for the project, subsequent review will not be necessary unless the design of the project or project procedures (including those potentially affecting data security) or principal investigator change. In these cases, a request for a revision must be submitted to CPHS for review before any project changes are implemented. Requests for revisions must be made through the CPHS web-based project submission system, e-Protocol.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

Projects that have been withdrawn or completed require a submission through the CPHS web-based project submission system, e-Protocol.For a complete list of instructions regarding e-Protocol, please refer to the CPHS e-Protocol User Manual here.

Please note that each Principal Investigator (PI), Responsible Official (RO), and any staff members must register on the system and have a unique User ID and password before you may submit your protocol. Registration is reviewed and approved by CPHS staff and can take up to three business days to complete.

The CPHS may revoke its approval if it is determined that changes in the project protocol or procedures or principal investigator have been carried out without prior CPHS approval.

HIPAA Waiver or Alteration of Authorization
Researchers may request a waiver or alteration of patient authorization under the Health Insurance Portability and Accountability Act (HIPAA). HIPAA waivers or alterations of authorization are only required when protected health information is first being requested and when there are any changes to the study that affect the HIPAA waiver or alteration. Only one IRB approval of waiver or alteration of patient authorization is required. If another IRB has approved the waiver or alteration, that documentation should be submitted to CPHS with the protocol as an attachment in the e-Protocol system.

Researchers with new project applications should complete the HIPAA section in the CPHS e-Protocol system.

Please note that some departments, such as the Office of Statewide Health Planning and Development, are not considered covered entities under HIPAA and do not require a waiver or alteration of patient authorization. Please check with each department for guidance.

CPHS Processes of Review

Common Rule New Projects
CPHS review is based upon 7 criteria delineated in the Common Rule (45 CFR 46.111) listed below.

Risks to subjects are minimized:

By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk; and

Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

Risks to subjects are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the CPHS will consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The CPHS will not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

Selection of subjects is equitable. In making this assessment the CPHS will take into account the purposes of the research and the setting in which the research will be conducted and will be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.

Informed consent (Appendix II) will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by 45 CFR 46.116.

Informed consent will be appropriately documented, in accordance with, and to the extent required by 45 CFR 46.117.

When appropriate, the research plan will make adequate provision for monitoring the data collected to ensure the safety of subjects.

When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

For projects involving vulnerable populations, the CPHS takes into consideration special protections outlined in the project application through the CPHS web-based project submission system, e-Protocol.

Researchers may request expedited review of projects involving data or materials previously collected for non-research purposes and that do not involve contact with human subjects.

Common Rule Continuing Projects
Review of continuing projects focuses on the following issues:

Have adverse events/unanticipated problems been appropriately addressed by the researchers and do these events increase risk for subjects?

Do interim findings justify continuation of the research project?

Has recent literature been appropriately reviewed by the researcher and does it support continuation of the research project?

Are currently approved informed consent documents still accurate and complete?

Are a currently approved waiver or alteration of informed consent and a HIPAA waiver or alteration of authorization still justified?

In addition, continuing projects will be reviewed for compliance with the Information Practices Act when state agencies are releasing personal information for purposes of the project.

Primary Reviewer System
CPHS utilizes a primary reviewer system in which one committee member is assigned to each project. This primary reviewer is responsible for initially reviewing the project, speaking with the principal investigator(s) before the committee meeting to address any questions and concerns, and presenting recommendations to the committee at convened meetings. The primary reviewer is subsequently responsible for reviewing proposed project changes and periodic continuing reviews of the project throughout its life. The primary reviewer serves as a main point of contact between the researcher and the CPHS.

Common Rule Expedited Review
CPHS may utilize expedited review for projects in three circumstances:

Review of minor changes to a previously approved project.

Review of minor changes in a new project that have been delineated at a convened CPHS meeting.

Periodic review of continuing projects without changes that: a) have been designated as minimal risk and no additional risks have been identified by the convened committee; b) have not yet enrolled human subjects; c) have no human subject involvement; d) have completed human subject involvement; and e) remain active only for long-term follow-up of subjects.

In circumstances 1 and 2 expedited review is conducted by a subcommittee consisting of the primary reviewer and the CPHS Chair or the Vice Chair. All subcommittee members must be in agreement for approval to be granted. In circumstance 3 expedited review is conducted by the primary reviewer alone. In general, expedited review decisions will be made within 4 weeks of receipt of the documents by CPHS members. Project proposals cannot be disapproved by the expedited review process and if not approved must be referred to the full CPHS for review. The primary reviewer may contact the researcher regarding changes that will help make the proposal approvable by expedited review.

HIPAA Review
The CPHS reviews applications for waivers of authorization or alterations of authorizations under HIPAA in conjunction with the review of new and continuing research projects under the Common Rule. The CPHS will not review research proposals solely for the purpose of granting waivers or alterations of authorization for HIPAA. Documentation must be submitted as described in the Submission of Documents section above. The three criteria that must be fulfilled for a HIPAA waiver or alteration of authorization are:

The research involves no more than minimal risk to the privacy of individuals based on:

An adequate plan to protect the protected health information from improper use and disclosure.

An adequate plan to destroy the protected health information at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the protected health information or such retention is required by law.

Adequate written assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be permitted.

The research could not practicably be conducted without the waiver or alteration of authorization.

The research could not practicably be conducted without access to and use of the protected health information.

Death Data Files
Projects exclusively using death data files (without living human subjects contact) may be evaluated through an expedited review of an abridged research protocol by the CPHS Chair and one CPHS member. Once approved, projects exclusively using death data files are not subject to continuing review unless there are changes to the protocol. Researchers with projects that have previously been approved by CPHS and are subsequently requesting use of death data should revise their existing protocol to incorporate the use of the death data (see the Review for Changes section for instructions on this process).

The CPHS assesses death data file projects based upon the validity of scientific interest. The following factors are considered:

Does the protocol provide background information that justifies the need for the research?

Will the study design adequately test the principal research questions of the study?

Will the information requested be necessary or sufficient to answer the principal research questions?

Will the privacy risks to the estates of deceased persons be appropriately minimized?

Will the data be appropriately protected both during and after the completion of the research?

Will the budget be adequate to complete the research?

Is the principal investigator professionally qualified to carry out the research?

California Information Practices Act Review
The CPHS is required, at a minimum, to determine:

That the requested personal information is needed to conduct the research.

That personal information released is not more than the minimum necessary to conduct the research.

That social security numbers are not released if other unique codes (not derived from the social security numbers) can be utilized.

The researcher has provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from threats to the security or confidentiality of the information.

The researcher has provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research project.

The researcher has provided sufficient written assurances that the personal information will not be reused or disclosed to any other person or entity not approved in the research protocol, except as required by law or for authorized oversight of the research project.

Convened Meetings
CPHS meetings are held on the first Friday of even-numbered months (February, April, June, August, October, and December) from 8:30 AM to 5:00 PM. Meetings are held at: 400 R Street, Room 300, Sacramento, CA. Information about upcoming meetings is available on the Public Meetings page of the OSHPD Website.

New Projects
For new projects requiring full committee review, principal investigators (PI) are expected to appear in person at the scheduled meeting. Telephone attendance may be acceptable if arranged in advance with the CPHS Administrator.

Continuing Projects
For continuing projects being reviewed by expedited review, PIs are not required to appear in person unless otherwise notified by the CPHS. Telephone attendance may be acceptable if arranged in advance with the CPHS Administrator. For projects requiring review by full committee, the PI should be prepared to appear in person or by phone, if previously arranged with the CPHS Administrator.

Bagley-Keene Act
All meetings are open to the public and conducted in compliance with the Bagley-Keene Act.

Committee Actions
The CPHS may take the following actions in convened meetings:

Tabled pending resolution of significant issues that will require full committee review

Not Approved

Determined to not be research

Determined to be exempt research

Determined to not be within CPHS purview

Notification and Appeal

Notification of Researchers
Researchers will receive written notification of CPHS actions from the Administrator within 3 weeks after convened meetings and within 4 weeks after submission of materials for expedited review. Researchers may receive verbal communications from the CPHS at convened meetings or from individual reviewers in the course of expedited review. However, researchers should not begin implementation of a project until written approval has been received from the Administrator. Also, if the convened committee makes suggestions for changes, the researcher is expected to wait for written notification of those changes from the Administrator before submitting changes to the CPHS.

Researchers are expected to forward copies of CPHS approval notifications to departments requesting such copies. CPHS does not routinely forward copies of notifications to department staff unless they are serving as principal investigators for the project.

Appeals of CPHS Actions
CPHS decisions cannot be cancelled or altered by another institutional review board, CHHS officials, or officials at a researcher’s institution. Appeals regarding CPHS decisions should be directed to the CPHS Administrator:

Reporting RequirementsIf an adverse event or unanticipated problems occurs, the Investigator is required to submit a Deviation through the CPHS web-based project submission system, e-Protocol within 48 hours of the event. For complete instructions on submitting a Deviation, please see corresponding section of the CPHS e-Protocol User Manual here. The definitions and examples of adverse events and unanticipated problems may be found at http://www.hhs.gov/ohrp/policy/advevntguid.html#Q1.This report is shared with CPHS members and is placed in the designated adverse event/unanticipated problem section of the project file. Some events must also be reported by CPHS to the Office of Human Research Protections.

CPHS ResponsibilitiesThe CPHS Chair or Vice Chair and the primary reviewer of the project are responsible for determining whether immediate action needs to be taken regarding the adverse event or unanticipated problem. The Chair may direct the Administrator to issue a notice to the principal investigator suspending the project approval and/or take other actions deemed necessary for subject safety until the project can be reviewed by the full committee at the next meeting. After review of the completed Deviation report, the CPHS can order termination or revision of a project to protect the welfare and safety of subjects. The CPHS reports all serious events, as appropriate, to the Secretary of the CHHS, the U.S. Office of Human Research Protection, the U.S. Food and Drug Administration, the funding agency (whether federal, state, or private), and the responsible official of the project.

Appendix I: Common Rule Research Project Protocol Requirements

You will be asked to submit a protocol through the CPHS web-based project submission system, e-Protocol. Please refer to the e-Protocol User Manual.

Appendix II: Informed Consent and Assent

Every potential research subject (or their legally authorized representative) has the right to be fully informed of the procedures, risks, and other aspects of the research before voluntarily choosing to participate. The potential research subject (or legally authorized representative) must be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion. The information provided for informed consent must be in language that is fully understandable to the subject or the legally authorized representative. Informed consent may not include exculpatory language through which the subject or the representative waives or appears to waive any legal rights, or that releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

Children 7-17 years of age must provide informed assent (as distinguished from "consent") to participate in research even if their parents or guardians have given permission for their participation through informed consent. The required elements of informed assent are very similar to the required elements of informed consent (see below).

Two Procedures for Written Informed Consent

Regular (or "long") form. This is the usual type of informed consent in which the subject is presented with a detailed, printed form to read and sign that provides complete information about all required elements of consent. Regular (or "long") form consent is designed to be fully informative.

"Short" form. In this type of informed consent the required elements of consent are explained orally to the subject by the investigator and the subject is asked to sign a form that summarizes the elements of consent. A witness must be present for the oral presentation and sign a copy of the summary. The project protocol must contain a verbatim transcript of the oral information to be presented to the subject (or legally authorized representative).

In general, the choice of "long" or "short" form consent is to be decided by the Principal Investigator based upon the risk of the research, the methodology of the research, and the characteristics and needs of the human subjects. If "short" form consent is chosen the principal investigator must provide solid justification in the project protocol.

General Priciples of Written Informed Consent

The informed consent form must begin with the official title of the research project. The title should reflect the purpose and intent of the study.

The form should next identify the principal investigator and the institution conducting the research.

The body of the form (elements 1-11) should be written using the pronoun "you", while the pronoun "I" should be used for the signed consent section (element 12). Because the purpose of the consent form is to obtain consent, as well as to confirm it, the body of the informed consent form must be written in conditional language that does not read as if the potential subject has already agreed to participate.

The form must be written in language that is fully understandable to the potential subjects. Scientific and technical terms should be avoided if simple, but equivalent words are available.

Required Elements of Informed Consent

The following elements must be included on the informed consent form using the headings as designated.

Purpose, Participation, and Procedures

This section should provide: a statement that the study involves research; an explanation of the purposes of the research; an explanation of how the potential subject was selected; an approximate number of subjects to be involved; the expected duration of the subject's participation; a description of the procedures to be followed; and identification of any procedures which are experimental.

Description of Risks

This section should provide a description of any reasonably foreseeable risks or discomforts to the subject. Risks may be physical, psychological, social, or economic. An assessment should be provided of the likelihood, severity, and duration of such risks. Levels of potential risk or discomfort must be accurately and clearly represented to potential subjects, and should not be unduly minimized. Any risk described in the project protocol should be addressed clearly in the informed consent form. A description should be provided of any less risky methods that were considered along with an explanation of why they will not be used. Research projects that collect or analyze personal information involve some degree of risk of loss of confidentiality for subjects. As with other risks, this should be accurately described to potential subjects.

Confidentiality

This section should provide a description of any measures that will be undertaken to protect the confidentiality of human subjects involved in the research. In general, statements guaranteeing complete confidentiality should not be made to potential subjects. If records may be subject to legal challenges, or certain information must be reported to law enforcement officials, this should be stated. If a federal certificate of confidentiality will be obtained, this should be described in this section.

Description of Benefits

This section should provide a description of any benefits to the subject or others that may be reasonably expected to result from the research. Neither compensation for participation in the activity nor the absence of costs or charges to subjects may be portrayed as benefits. If no benefits for the subjects are expected, that should be clearly stated.

Alternative Procedures

This section should describe any similar or equivalent procedures or treatments that may be available to potential research subjects who do not choose to participate in the research. For example, potential subjects may be able to request a similar test or treatment from their personal physician. If no alternative procedures or treatments are available, that should be stated.

Compensation

This section should clearly describe the value and circumstances for receipt of any money or other compensation for participation in the study. If no compensation is to be received, this should be stated. The absence of costs or charges to the subject cannot be considered compensation.

Treatment for Injury

If the research is greater than minimal risk, describe any treatment that will be available if any injury occurs to the subject as a result of the research and provide information about where treatment information may be obtained. If treatment will not be available, this should be stated.

Potential Conflict of Interest and Funding

This section should describe any financial or other relationship interests the researcher may have that may potentially affect the performance of the research or how results of the research are interpreted. In addition, the funding source or sponsor of the research must be identified.

Questions

This section should provide information about: 1) who to contact with questions about the research (usually the principal investigator), and 2) who to contact with questions about research subjects’ rights (usually an institutional review board, an ethics board, or other oversight panel). If another board or panel is not reviewing the project, the subjects may be instructed to contact: Administrator, Committee for the Protection of Human Subjects, California Health and Human Services Agency (916-326-3660, cphs-mail@oshpd.ca.gov) for information about research subjects’ rights.

Voluntary Participation

This section should provide a clear statement that participation in the research is voluntary and that refusal to participate or withdrawal from the research at any point will not result in any penalty or loss of benefits to which the subject is otherwise entitled.

Research Participant's Bill of Rights

This section should include a statement that the subject is being given a copy of the Research Participant's Bill of Rights in addition to the informed consent form. For medical experiments California law (Health and Safety Code, Section 24172) requires that the "California Research Participant's Bill of Rights" (Appendix III) be used. The Spanish version of this document is also included in Appendix III. Medical experiments are defined in Section 24174 as:

"(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject.
(b) The investigational use of a drug or device as provided in Sections 111590 and 111595.
(c) Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject."

For non-medical research the "Research Participant's Bill of Rights for Non-Medical Research" (Appendix IV) should be used. The Spanish version of this document is also included in Appendix IV. The researcher may submit alternative versions of the bill of rights for non-medical research for CPHS approval.

A copy of the approved medical or non-medical bill of rights must be attached to the consent form given to the subject.

Consent Statement and Signiture

This is a signed and dated statement that the subject gives consent to participate in the research study and has received a copy of the Research Participant's Bill of Rights. For this statement the pronoun "I" should be used. If applicable, space should be provided for the signature of a witness. In certain circumstances the signatures of both parents may be required for children who are involved in research (see CFR §46.408).

Additional Elements of Informed Consent

When appropriate, information on one or more of the following elements should be included in the consent form:

A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable.

Anticipated circumstances under which the subject's participation may be terminated by the investigator without the subject's consent.

Any additional costs to the subject that may result from participation in the research.

The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.

A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject.

For research involving subjects with severe psychiatric disorders: a statement regarding (a) whether the treating psychiatrists are also members of the research team, and (b) whether study medications are determined by clinical need or dictated by the research protocol.

For research involving test articles regulated by the Food and Drug Administration (FDA): a statement that the purpose of the study includes evaluation of both the safety and the effectiveness of the test article.

Specifics on the methods, amounts, and timing of any proposed taking of blood or any other human materials, and their subsequent disposal.

Details regarding the use of tape recorders or other audio or visual recordings, and an explanation of the proposed uses and disposition of such materials.

Assurance that should the investigator discover any untoward medical condition or inheritable disorder in the subject, this will be brought, if possible, to the attention of the subject’s own physician, or the subject will be informed of the condition and advised to seek proper assistance.

Informed Assent

While the intent of informed assent is the same as that of informed consent, the informed assent form must be written at a level that is understandable to potential subjects who are children between 7-17 years of age. Different informed assent forms may be needed if the study involves children of significantly different ages.

The same headings must be used as for informed consent. Because some children cannot read through as long a form as an adult, assent forms may be shortened to facilitate reading and understanding by children. However, all of the required elements of the informed consent still must be adequately addressed.

Waiver or Alteration of Informed Consent
The CPHS may approve the use of a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent if Criteria A or Criteria B (below) apply.

Criteria A.

The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs; and

The research could not practicably be carried out without the waiver or alteration.

Criteria B.

The research involves no more than minimal risk to the subjects;

The waiver or alteration will not adversely affect the rights and welfare of the subjects;

The research could not practicably be carried out without the waiver or alteration; and

Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Waiver of Written Informed Consent
The CPHS may grant a waiver of the requirement for written informed consent under carefully justified circumstances as follows:

The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject must be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

Examples of projects for which the CPHS may consider requests for waivers of written consent include: projects in which the research subjects are illiterate; projects in which the risks (usually psychological risks) inherent in asking subjects for their signatures outweigh the risks of not obtaining the signatures; projects in which requests for signatures demonstrably violate or distort the subjects' perceptions of the nature and purpose of the investigation; and interview studies in which the subjects will read and keep the information contained in a consent document.

The waiver of written informed consent does not eliminate the investigator's ethical and legal obligation to obtain the prior consent of subjects for participation in the research activity.

Appendix III: Participant's Bill of Rights for Medical Research (English and Spanish)

Any person who is asked to participate as a human subject in a research study, or who is asked to consent on behalf of another, has the following rights:

Be informed of the nature and purpose of the study.

Be given an explanation of the procedures to be followed in the study, and any drug or device to be utilized.

Be given a description of any attendant discomforts and risks reasonably to be expected from the study.

Be given an explanation of any benefits to the subject reasonably to be expected from the study, if applicable.

Be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous to the subject, and their relative risks and benefits.

Be informed of the avenues of medical treatment, if any, available to the subject after the study if complications should arise.

Be given an opportunity to ask any questions concerning the study or the procedures involved.

Be instructed that consent to participate in the study may be withdrawn at any time and the subject may discontinue participation in the study without prejudice.

Be given a copy of the signed and dated written consent form.

Be given the opportunity to decide to consent or not to consent to a study without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on the subject's decision.

You will be asked to submit a protocol through the CPHS web-based project submission system, e-Protocol. Please refer to the e-Protocol User Manual.

Appendix VIII: Guidance for Using Small Numbers or Small Cells

Definition of a small cell or a small number

A cell is the intersection of a row and a column in a table, a spreadsheet, or in any matrix of numbers. For example, a table with four rows and three columns has twelve cells;

The CPHS considers a cell small when it contains 1 to 15 research subjects;

Some projects do not report data as tables but still might describe the characteristics of small numbers of subjects. Whenever a project describes 1 to 15 subjects it is important to be especially careful that the identities of all subjects are protected from possible disclosure.

Why small numbers or small cells are potential problemsA small number of subjects in a descriptive report or small cells in a table could potentially lead to the unintended identification of a research subject’s identity. With a small study population, or with a small subset of a larger population, researchers should be careful about possibly identifying subjects. For example, research subjects in a rural community might be easily identified because their community has only one or two instances of a particular disease. Similarly, multiple tables describing an urban community might allow for the deduction of a subject’s identity through a process of subtraction involving cells if the numbers in them are sufficiently small.

Suggested methods for dealing with small cells or small numbers

Eliminate tables with small cells or data descriptions with small numbers:
Within a table, combine (collapse) the row (or column) containing a small cell with another row (or column) to increase cell size;

Combine the different time periods, such as fiscal years, represented by two or more tables (or descriptions) into a single table (or description) to increase cell size (or number size);

Suppress a small cell with a non-numeric symbol that hides the number of subjects, (for example {sc}). To prevent the identification of a small cell through subtraction, the suppression symbol should appear at least twice in the row and column of each of its intersections, as in the following example.

> 65 yrs

18-64 yrs

< 18 yrs

TOTAL

agree

{sc}

30

{sc}

60

neutral

{sc}

60

{sc}

150

disagree

70

90

80

240

undecided

0

0

0

0

TOTAL

120

180

150

450

Use of these suggested methods is recommended but not required by the CPHS. Researchers may request approval from CPHS for using alternative methods to protect subject identity when using small cells or small numbers.